Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
1–24 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 20, 2026
BD OneFlow LST
K260215 · PWD
Bd Biosciences
Immunology · 270d
Cleared Sep 04, 2026
IMMULITE 2000 3gAllergy Specific IgE Vantage
K260331 · DHB
Siemens Healthcare Diagnostics...
Immunology · 214d
Cleared Aug 21, 2026
Alegria Flash MPO
K261466 · MOB
Zeus Scientific
Immunology · 109d
Cleared Aug 21, 2026
IDS SS-A/Ro
K253817 · LLL
Immunodiagnostics Systems Limited
Immunology · 266d
Cleared Aug 19, 2026
Elecsys Phospho-Tau (217P) Plasma
K261686 · SET
Roche Diagnostics
Immunology · 90d
Cleared Aug 19, 2026
PrecivityAD2 Test
K253240 · SET
C2N Diagnostics, LLC
Immunology · 324d
Cleared Aug 10, 2026
Atellica IM CA 19-9 II
K253528 · NIG
Siemens Healthcare Diagnostics, Inc.
Immunology · 270d
Cleared Jul 24, 2026
NOVEOS Specific IgE (sIgE)
K261027 · DHB
Hycor Biomedical
Immunology · 116d
Cleared Jul 21, 2026
NOVEOS Specific IgE (sIgE)
K260591 · DHB
Hycor Biomedical
Immunology · 148d
Cleared Jun 25, 2026
EliA CTD 13 Screen
K253367 · LLL
Phadia AB
Immunology · 268d
Cleared Jun 18, 2026
NOVEOS Specific IgE (sIgE)
K260280 · DHB
Hycor Biomedical
Immunology · 140d
Cleared May 15, 2026
NOVEOS Specific IgE (sIgE)
K260059 · DHB
Hycor Biomedical
Immunology · 127d
Cleared May 08, 2026
Alegria Flash SSA-60
K250814 · OBE
Zeus Scientific
Immunology · 417d
Cleared Apr 24, 2026
Diazyme Immunoglobulin A Assay
K252336
Diazyme Laboratories, Inc.
Immunology · 270d
Cleared Feb 06, 2026
Aptiva APS IgA Reagent
K243979 · MSV
Inova Diagnostics, Inc.
Immunology · 410d
Cleared Jan 16, 2026
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea)
K252775 · DHB
Hycor Biomedical
Immunology · 136d
Cleared Jan 05, 2026
Atellica IM Total PSA II (tPSAII)
K251630 · LTJ
Siemens Healthcare Diagnostics, Inc.
Immunology · 222d
Cleared Dec 23, 2025
NOVEOS Specific IgE (sIgE)
K252493 · DHB
Hycor Biomedical
Immunology · 137d
Cleared Dec 19, 2025
Diazyme Human Kappa (k) Free Light Chain Assay
K253358 · DFH
Diazyme Laboratories, Inc.
Immunology · 80d
Cleared Dec 16, 2025
ADVIA Centaur Cytokeratin Fragment 21-1
K250925 · OVK
Fujirebio Diagnostics,Inc.
Immunology · 264d
Cleared Dec 04, 2025
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · JNL
Siemens Healthcare Diagnostics, Inc.
Immunology · 261d
Cleared Oct 22, 2025
Alegria Flash CTD Screen
K250666 · LLL
Zeus Scientific
Immunology · 231d
Cleared Oct 17, 2025
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250 · JZO
Siemens Healthcare Diagnostics, Inc.
Immunology · 262d
Cleared Oct 17, 2025
Immunoglobulin Isotypes (GAM) for the EXENT Analyser
K250159 · SGG
The Binding Site Group , Ltd.
Immunology · 269d